Sevelamer carbonate Winthrop: detailed information

Package leaflet: Information for the user

Sevelamer Carbonate Winthrop 800 mg film-coated tablets

sevelamer carbonate
Read this entire leaflet carefully before you start taking this medicine
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What Sevelamer Carbonate Winthrop is and what it is used for
What you need to know before taking Sevelamer Carbonate Winthrop
How to take Sevelamer Carbonate Winthrop
Possible side effects
How to store Sevelamer Carbonate Winthrop
Contents of the pack and other information

1. What Sevelamer Carbonate Winthrop is and what it is used for

Sevelamer Carbonate Winthrop contains the active substance sevelamer carbonate, which acts in the digestive system by preventing the absorption of phosphate from food, thereby reducing phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
patients with chronic kidney disease (long-standing) who are not on dialysis and who have a serum phosphate level equal to or greater than 1.78 mmol/l.

This medicine should be used in combination with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disorders.
Elevated levels of phosphorus in the blood can lead to the formation of solid deposits in the body known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer Carbonate Winthrop

Do not take Sevelamer Carbonate Winthrop

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have low levels of phosphate in the blood (your doctor will check this)
if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Sevelamer Carbonate Winthrop:

if you have difficulty swallowing. Your doctor may alternatively prescribe Sevelamer Carbonate Winthrop oral suspension powder
if you have problems with motility (movement) of the stomach and intestines
if you have active inflammation of the intestine
if you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Sevelamer Carbonate Winthrop:

if you experience severe abdominal pain, stomach or intestinal problems, or if you notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether to continue or discontinue treatment.

Additional treatments:
Due to kidney disease or dialysis treatment, you may:

develop low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements,
have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamins A, E, K, and folic acid in the blood, and your doctor may monitor these levels and prescribe vitamin supplements as needed,
have altered levels of bicarbonate in the blood and increased blood acidity (and in other body tissues). Your doctor will monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis:
You may be at risk of peritonitis (infection of the abdominal fluid) related to peritoneal dialysis.
This risk can be reduced by strictly following sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms such as abdominal discomfort, abdominal distension, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
Do not give this medicine to children under 6 years of age, as the safety and efficacy in children (under 6 years) have not been established.
Other medicines and Sevelamer Carbonate Winthrop
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Sevelamer Carbonate Winthrop must not be taken at the same time as ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm disorders or epilepsy, consult your doctor when taking Sevelamer Carbonate Winthrop.
Sevelamer Carbonate Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Sevelamer Carbonate Winthrop has uncommonly led to thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels more closely.
Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer Carbonate Winthrop. Your doctor may consider monitoring your blood phosphate levels.

Your doctor will regularly check for possible interactions between Sevelamer Carbonate Winthrop and other
medicines.
In some cases where Sevelamer Carbonate Winthrop must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Carbonate Winthrop. Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
The potential risk of Sevelamer Carbonate Winthrop during human pregnancy is unknown. Discuss with your doctor, who will decide whether you can continue treatment with Sevelamer Carbonate Winthrop.
It is not known whether Sevelamer Carbonate Winthrop is excreted in breast milk and whether it could affect the infant. Inform your doctor, who will decide whether you can breastfeed and whether treatment with Sevelamer Carbonate Winthrop needs to be discontinued.
Driving and using machines
It is unlikely that Sevelamer Carbonate Winthrop affects the ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Sevelamer Carbonate Winthrop

You must take this medicine exactly as prescribed by your doctor. Your doctor will base the dose on your blood phosphate levels.
The recommended starting dose of this medicine in tablet form, for adults and elderly patients, is one or two 800 mg tablets, taken three times a day with main meals. Check with your doctor, pharmacist, or nurse if you are unsure.
Take Sevelamer Carbonate Winthrop after a meal or with food.
The tablets must be swallowed whole. Do not crush, chew, or break the tablets.
Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of Sevelamer Carbonate Winthrop as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer Carbonate Winthrop than you should
In case of a possible overdose, contact your doctor immediately.

If you forget to take Sevelamer Carbonate Winthrop
If you forget a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Sevelamer Carbonate Winthrop
Continuing treatment with Sevelamer Carbonate Winthrop is important to maintain appropriate phosphate levels in the blood. Stopping Sevelamer Carbonate Winthrop could lead to serious consequences, such as calcification of blood vessels. If you are considering stopping treatment with Sevelamer Carbonate Winthrop, contact your doctor or pharmacist first.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect. It may be an initial symptom of intestinal blockage. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, consult your doctor immediately:

Allergic reaction (signs include rash, hives, swelling, breathing difficulties). This is a very rare side effect (may affect up to 1 in 10,000 people).
Intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is not known.
Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is not known.
Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is not known.

Other side effects observed in patients taking Sevelamer Carbonate Winthrop are:
Very common (may affect more than 1 in 10 people):

vomiting,
upper abdominal pain,
nausea.

Common (may affect up to 1 in 10 people):

diarrhoea,
stomach pain,
indigestion,
flatulence.

Not known (frequency cannot be estimated from the available data):

cases of itching,
skin rash,
reduced intestinal motility (movement).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevelamer Carbonate Winthrop

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp".
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sevelamer Carbonate Winthrop contains

The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
The excipients are microcrystalline cellulose, sodium chloride, zinc stearate.

Description of the appearance of Sevelamer Carbonate Winthrop and package contents
Sevelamer Carbonate Winthrop film-coated tablets are white or almost white oval tablets, with "RV800" engraved on one side. The tablets are packaged in high-density polyethylene bottles with a child-resistant polypropylene cap and an induction seal closure.
Pack sizes:
Each bottle contains 30 or 180 tablets.
Pack of 1 bottle containing 30 or 180 tablets without outer carton.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer:
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Sanofi Winthrop Industrie
1 rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc cedex
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien/Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00
Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
From abroad: +33 1 57 63 23 23

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 201 200 300

Italia
Sanofi S.r.l.
Tel: 800 536 389

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Package leaflet: Information for the user

Sevelamer Carbonate Winthrop 0.8 g oral suspension powder

sevelamer carbonate
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

What Sevelamer Carbonate Winthrop is and what it is used for
What you need to know before taking Sevelamer Carbonate Winthrop
How to take Sevelamer Carbonate Winthrop
Possible side effects
How to store Sevelamer Carbonate Winthrop
Contents of the pack and other information

1. What Sevelamer Carbonate Winthrop is and what it is used for

adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
adult patients with chronic kidney disease who are not on dialysis and have a serum phosphate level equal to or greater than 1.78 mmol/l;
paediatric patients with chronic kidney disease (long-standing) over 6 years of age and above a certain height and weight (used by the doctor to calculate body surface area).

This medicine should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone diseases. Elevated phosphate levels in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make blood circulation throughout the body more difficult. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer Carbonate Winthrop

Do not take Sevelamer Carbonate Winthrop

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have low levels of phosphate in the blood (your doctor will monitor this)
if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Sevelamer Carbonate Winthrop:

if you have problems with motility (movement) of the stomach and intestines
if you have active inflammation of the intestine
if you have undergone major surgery on the stomach or intestines

Talk to your doctor during treatment with Sevelamer Carbonate Winthrop:

if you experience severe abdominal pain, stomach or intestinal disturbances, or if you notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether to continue or discontinue treatment.

Additional treatments:
Due to kidney disease or dialysis treatment, you may:

develop low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements,
have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and your doctor may monitor these levels and prescribe vitamin supplements as needed,
have altered levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor must monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis:
You may be at risk of peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
Do not give this medicine to children under 6 years of age, as the safety and efficacy in children (under 6 years) have not been studied.
Other medicines and Sevelamer Carbonate Winthrop
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Sevelamer Carbonate Winthrop must not be taken at the same time as ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm disorders or for epilepsy, consult your doctor when taking Sevelamer Carbonate Winthrop.
Sevelamer Carbonate Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Sevelamer Carbonate Winthrop has uncommonly caused thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels more closely.
Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer Carbonate Winthrop. Your doctor may consider monitoring your blood phosphate levels.
.

Your doctor will regularly check for possible interactions between Sevelamer Carbonate Winthrop and other medicines.
In some cases where Sevelamer Carbonate Winthrop must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Carbonate Winthrop.
Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The potential risk of Sevelamer Carbonate Winthrop during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Sevelamer Carbonate Winthrop.
It is not known whether Sevelamer Carbonate Winthrop is excreted in breast milk or whether it may affect the infant. Inform your doctor, who will decide whether you can breastfeed and whether treatment with Sevelamer Carbonate Winthrop needs to be discontinued.
Driving and using machines
It is unlikely that Sevelamer Carbonate Winthrop will affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially "sodium-free".
This medicine contains 8.42 mg of propylene glycol per 0.8 g sachet.

3. How to take Sevelamer Carbonate Winthrop

You must take this medicine exactly as instructed by your doctor. Your doctor will determine the dose based on your blood phosphate levels.
For a dosage of 0.8 g, the oral suspension powder must be dissolved in 30 ml of water per sachet. Drink within 30 minutes of preparation. It is important that you drink all the liquid, and you may need to rinse the glass with water and drink again to ensure you ingest all the powder.
Instead of water, the powder may be mixed with a small amount of cold beverage (approximately 120 ml or half a glass) or food (approximately 100 g) and consumed within 30 minutes. Do not heat Sevelamer Carbonate Winthrop powder (e.g., in a microwave), and do not add it to hot food or liquids.
The recommended initial dose of Sevelamer Carbonate Winthrop for adults and elderly patients is 2.4–4.8 g/day, divided equally among the three main meals. If you are unsure, check with your doctor, pharmacist, or nurse.
Your doctor will decide the appropriate initial dose and dosing regimen.
Take Sevelamer Carbonate Winthrop with meals or immediately after meals.

(Instructions for packaging with dosing spoon)
For doses of 0.4 g, the powder in the sachet may be divided. In this case, the 0.4 g dose of Sevelamer Carbonate Winthrop powder should be measured using the dosing spoon provided in the package.
Always use the dosing spoon provided in the package.

(Instructions for packaging WITHOUT dosing spoon)
If a dose of 0.4 g must be administered, use the specific 0.8 g powder sachet with dosing spoon.

Use in children and adolescents
The recommended initial dose of Sevelamer Carbonate Winthrop tablets for children is based on their height and weight (used by the doctor to calculate body surface area). For children, the powder formulation is preferred, as tablets are not suitable for this population. This medicine must not be taken on an empty stomach and should be taken with meals or snacks. The appropriate initial dose and dosing regimen will be determined by your doctor.
For doses below 0.8 g, the powder in the sachet may be divided. The 0.4 g dose of Sevelamer Carbonate Winthrop powder should be measured using the dosing spoon provided in the package.

Preparation using a dosing spoon
Use the dosing spoon provided for each 0.4 g dose of Sevelamer Carbonate Winthrop powder.
For a 0.4 g dose:

Shake the sachet, holding the top corner before opening, to move the powder to the bottom of the sachet.
Open the sachet by cutting along the marked line.
Ensure the dosing spoon is dry.
Hold the dosing spoon horizontally and pour the powder from the sachet into the spoon.
Fill the spoon to the top level.
Do not tap the dosing spoon to compact the powder.
Pour the powder from the dosing spoon into 30 ml of water. Stir the suspension and drink within 30 minutes of preparation. It is important that you drink all the liquid to ensure complete ingestion of the powder.
Close the sachet by folding it over twice.
The remaining powder may be used within 24 hours for the next dose.
Discard any sachets that have been left open for more than 24 hours.

Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of Sevelamer Carbonate Winthrop as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer Carbonate Winthrop than you should
In case of a suspected overdose, contact your doctor immediately.

If you forget to take Sevelamer Carbonate Winthrop
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Sevelamer Carbonate Winthrop
Continuing treatment with Sevelamer Carbonate Winthrop is important to maintain appropriate phosphate levels in the blood. Stopping Sevelamer Carbonate Winthrop may lead to serious consequences, such as vascular calcification. If you are considering stopping treatment with Sevelamer Carbonate Winthrop, contact your doctor or pharmacist first.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Constipation is a very common side effect. It may be an early sign of intestinal blockage. If you experience constipation, inform your doctor or pharmacist.

Some side effects may be serious. If you experience any of the following side effects, contact your doctor immediately:

Allergic reaction (signs include rash, hives, swelling, breathing difficulties). This is a very rare side effect (may affect up to 1 in 10,000 people).
Intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown.
Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is unknown.
Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in stools [gastrointestinal bleeding]) and crystal deposition in the intestine. Frequency is unknown.

Other side effects observed in patients taking Sevelamer Carbonate Winthrop include:
Very common (may affect more than 1 in 10 people):

vomiting,
upper abdominal pain,
nausea.

Common (may affect up to 1 in 10 people):

diarrhoea,
stomach pain,
indigestion,
flatulence.

Not known (frequency cannot be estimated from the available data):

cases of itching,
skin rash,
reduced intestinal motility (movement).

5. How to store Sevelamer Carbonate Winthrop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after "Exp".
The expiry date refers to the last day of that month.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.
(Instructions for the pack containing the dosing spoon)
Discard the sachet after 24 hours from opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sevelamer Carbonate Winthrop contains

The active substance is sevelamer carbonate. Each sachet of Sevelamer Carbonate Winthrop contains 0.8 g of sevelamer carbonate.
The excipients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and yellow iron oxide (E172).

Description of the appearance of Sevelamer Carbonate Winthrop and contents of the pack
Sevelamer Carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in an aluminium foil sachet with a heat-sealed closure. The sachets are packed in an outer carton.
(Instructions for packaging with dosing spoon)
A 0.4 g dosing spoon is provided in the carton.
Pack sizes:
90 sachets per carton
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares,
Madrid, 28805, Spain
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien/Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00
Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40
България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480
Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050
Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111
Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Danmark
Sanofi A/S
Tlf: +45 45 16 70 00
Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131
Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30
Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 - 0
Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600
Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400
France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
From abroad: +33 1 57 63 23 23
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00
Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600
Ísland
Vistor hf.
Sími: +354 535 7000
Suomi/Finland
Sanofi Oy
Puh/Tel: +358 201 200 300
Italia
Sanofi S.r.l.
Tel: 800 536 389
Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00
Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: Information for the user

Sevelamer Carbonate Winthrop 2.4 g oral suspension powder

sevelamer carbonate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

What Sevelamer Carbonate Winthrop is and what it is used for
What you need to know before taking Sevelamer Carbonate Winthrop
How to take Sevelamer Carbonate Winthrop
Possible side effects
How to store Sevelamer Carbonate Winthrop
Package contents and other information

1. What Sevelamer Carbonate Winthrop is and what it is used for

adult patients on dialysis (a blood purification technique). The medicine can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood);
adult patients with chronic kidney disease who are not on dialysis and who have a serum phosphate level equal to or greater than 1.78 mmol/l;
paediatric patients with chronic kidney disease (long-standing) above the age of 6 years and above certain height and weight thresholds (used by the physician to calculate body surface area).

This medicine should be used in conjunction with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease. Elevated phosphate levels in the blood can lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased phosphate levels in the blood may cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer Carbonate Winthrop

Do not take Sevelamer Carbonate Winthrop

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have low levels of phosphate in the blood (your doctor will check this)
if you have intestinal obstruction.

Warnings and precautions
Talk to your doctor before taking Sevelamer Carbonate Winthrop:

if you have problems with motility (movement) of the stomach and intestines
if you have active inflammation of the intestine
if you have undergone major surgery on the stomach or intestines.

Talk to your doctor during treatment with Sevelamer Carbonate Winthrop:

if you experience severe abdominal pain, stomach or intestinal discomfort, or if you notice blood in your stools (gastrointestinal bleeding). These symptoms may be due to deposition of sevelamer crystals in your intestine. Contact your doctor, who will decide whether to continue or discontinue treatment.

Additional treatments:
Due to kidney disease or dialysis treatment, you may:

have low or high levels of calcium in the blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements,
have low levels of vitamin D in the blood. Therefore, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood, and therefore your doctor may monitor these levels and prescribe vitamin supplements as needed,
have altered levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor must monitor your blood bicarbonate levels.

Special note for patients undergoing peritoneal dialysis:
You may be at risk of developing peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strictly maintaining sterile techniques when changing dialysis bags. Inform your doctor immediately if you develop new signs or symptoms of abdominal discomfort, abdominal distension, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.
Children
Do not give this medicine to children under 6 years of age, as the safety and efficacy in children (under 6 years) have not been studied.
Other medicines and Sevelamer Carbonate Winthrop
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Sevelamer Carbonate Winthrop must not be taken at the same time as ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm disorders or epilepsy, consult your doctor when taking Sevelamer Carbonate Winthrop.
Sevelamer Carbonate Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Sevelamer Carbonate Winthrop has uncommonly caused thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels in the blood more closely.
Medicines such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer Carbonate Winthrop. Your doctor may consider monitoring phosphate levels in the blood.

Your doctor will regularly check for possible interactions between Sevelamer Carbonate Winthrop and other medicines.
In some cases where Sevelamer Carbonate Winthrop must be taken at the same time as another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Carbonate Winthrop.
Your doctor may also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
The potential risk of Sevelamer Carbonate Winthrop during human pregnancy is unknown. Discuss with your doctor, who will decide whether you can continue treatment with Sevelamer Carbonate Winthrop.
It is not known whether Sevelamer Carbonate Winthrop is excreted in breast milk and whether it may affect the infant. Inform your doctor, who will decide whether you can breastfeed and whether treatment with Sevelamer Carbonate Winthrop needs to be discontinued.
Driving and using machines
It is unlikely that Sevelamer Carbonate Winthrop will affect your ability to drive or operate machinery.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially "sodium-free".
This medicine contains 25.27 mg of propylene glycol per 2.4 g sachet.

3. How to take Sevelamer Carbonate Winthrop

Take this medicine exactly as instructed by your doctor.
Your doctor will determine your dose based on your blood phosphate levels.
For a 2.4 g dose, the oral suspension powder must be dissolved in 60 ml of water for each sachet. Drink within 30 minutes of preparation. It is important to drink all the liquid, and you may need to rinse the glass with water and drink again to ensure you have taken all the powder.
Instead of water, the powder may be mixed with a small amount of cold drink (approximately 120 ml or half a glass) or food (approximately 100 g) and consumed within 30 minutes. Do not heat Sevelamer Carbonate Winthrop powder (e.g. in a microwave) and do not add it to hot food or liquids.
The recommended initial dose of Sevelamer Carbonate Winthrop for adults and elderly patients is 2.4–4.8 g/day, divided equally among the three main meals. Check with your doctor, pharmacist, or nurse if you are unsure.
Your doctor will decide the correct initial dose and dosing regimen.
Take Sevelamer Carbonate Winthrop after meals or with food.
If you need to administer a 0.4 g dose, use the special 0.8 g powder sachet with dosing spoon provided.

Use in children and adolescents
The recommended initial dose of Sevelamer Carbonate Winthrop tablets for children is based on their height and weight (used by the doctor to calculate body surface area). For children, the powder formulation is preferred, as tablets are not suitable for this population. This medicine must not be administered on an empty stomach and should be taken with meals or snacks. The correct initial dose and regimen will be determined by your doctor.
Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of Sevelamer Carbonate Winthrop as necessary to achieve the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer Carbonate Winthrop than you should
In case of a possible overdose, contact your doctor immediately.

If you forget to take Sevelamer Carbonate Winthrop
If you miss a dose, take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you stop taking Sevelamer Carbonate Winthrop
Continuing treatment with Sevelamer Carbonate Winthrop is important to maintain appropriate phosphate levels in the blood. Stopping Sevelamer Carbonate Winthrop may lead to serious consequences such as calcification of blood vessels. If you are considering stopping treatment with Sevelamer Carbonate Winthrop, contact your doctor or pharmacist first.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Constipation is a very common side effect. It may be an early sign of intestinal blockage. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, contact your doctor immediately:

Allergic reaction (signs include skin rash, hives, swelling, breathing difficulties). This is a very rare side effect (may affect up to 1 in 10,000 people).
Intestinal blockage (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown.
Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency is unknown.
Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disturbances, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency is unknown.

Other side effects observed in patients taking Sevelamer Carbonate Winthrop include:
Very common (may affect more than 1 in 10 people):

vomiting,
upper abdominal pain,
nausea.

Common (may affect up to 1 in 10 people):

diarrhoea,
stomach pain,
indigestion,
flatulence.

Not known (frequency cannot be estimated from the available data):

cases of itching,
skin rash,
reduced intestinal motility (movement).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevelamer Carbonate Winthrop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after "Exp".
The expiry date refers to the last day of that month.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sevelamer Carbonate Winthrop contains

The active substance is sevelamer carbonate. Each sachet of Sevelamer Carbonate Winthrop contains 2.4 g of sevelamer carbonate.
The excipients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and yellow iron oxide (E172).

Description of the appearance of Sevelamer Carbonate Winthrop and contents of the pack
Sevelamer Carbonate Winthrop oral suspension powder is a pale yellow powder supplied in an aluminium foil sachet with a heat-sealed closure. The sachets are packed in an outer carton.
Packs:
60 sachets per carton
90 sachets per carton
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares
Madrid, 28805, Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България (Bulgaria)
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország (Hungary)
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Česká republika (Czech Republic)
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark (Denmark)
Sanofi A/S
Tlf: +45 45 16 70 00

Nederland (Netherlands)
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland (Germany)
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Eesti (Estonia)
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich (Austria)
sanofi-aventis GmbH
Tel: +43 1 80 185 - 0

Ελλάδα (Greece)
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska (Poland)
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España (Spain)
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From abroad: +33 1 57 63 23 23

România (Romania)
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Hrvatska (Croatia)
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija (Slovenia)
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenská republika (Slovakia)
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland (Iceland)
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 201 200 300

Italia (Italy)
Sanofi S.r.l.
Tel: 800 536 389

Sverige (Sweden)
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος (Cyprus)
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Latvija (Latvia)
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.